Will Smart Insulin Pens Hit Pharmacy Shelves Soon?

Thinking beyond the pill is becoming the new mantra for Big Pharma. In an industry that has been plagued by many drugs going generic and most prominent blockbuster drugs being relegated to the specialty market, finding a new niche has been a focus.

Digital health has become increasingly attractive to pharma as a means of not only finding new areas for therapeutic investigations but also as a way to tie in drugs to "one-up" competitors with a more versatile product. This could be anything from an application to increase adherence to therapy to a service meant to treat the disease more holistically.

Case in point: Eli Lilly is starting research on a new project whereby it is creating a closed-loop system for diabetes management. So how does this work? Essentially, the future of diabetes management with insulin will not be standalone pumps or pens but rather devices that are integrated together with real-time data analytics to administer insulin at the right dose and right time. So how does this all work?

Eli Lilly is calling it the automated insulin delivery (AID) system, which it detailed in a statement as "a hybrid closed-loop platform that uses connected devices -- an insulin pump with a dedicated controller, dosing algorithm, and continuous glucose monitor -- to automate insulin dosing. These components are designed to work together to automatically adjust insulin infusion rates to maintain blood sugar levels within a specified target range."¹ This will be part of the Connected Diabetes Ecosystem, which will first need to demonstrate safety and functionality in a phase I study. What is interesting is that in another part of the statement, Eli Lilly said, "The AID system is one of 2 platforms in development for the Ecosystem. The other is an integrated insulin management system, which combines a connected insulin pen with glucose-sensing technologies and software applications to deliver personalized insulin dose recommendations. Both platforms within the Ecosystem are currently in development, and more clinical trials will be initiated in the coming months in both people with type 1 and type 2 diabetes who use insulin. In conjunction with a variety of partners, Lilly is working to make these platforms available to patients within 2 to 3 years, pending FDA approval."

This second part is novel but not unexpected, given that Eli Lilly has for some time been making moves to get a smart insulin pen working. It bought a start-up a few years ago, and other data have indicated that it sees this as a serious new venture to get into.² Consider it similar to how Otsuka teamed up with Proteus to create a smart pill to monitor medication adherence. In this case, a smart insulin pen would not only follow the patient's insulin use but also sensor technology for blood glucose and give recommendations, which is a vastly new therapeutic realm to consider.

Again, as we are seeing increasingly digitalized medications being developed and coming to market, I have to wonder what role pharmacists will play. I can only assume that new education or training would be needed, even if just in the specialty space, to provide instruction on how to use these devices and educate patients not only on their appropriate use but how to set them up and connect them to other software or devices to make sure that such a closed-loop system works.

References

1. Lilly initiates clinical trial to evaluate the functionality and safety of its automated insulin delivery system [news release]. Indianapolis, IN: December 5, 2017. investor.lilly.com/releasedetail.cfm?ReleaseID=1050744. Accessed December 22, 2017.

2. Hoskins, M. Lilly developing its own insulin pen and smart pen device. Healthline. healthline.com/diabetesmine/news-lilly-developing-insulin-pump-smart-pen-device#1. Published November 30, 2017. Accessed December 22, 2017.